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19.02.2013 Views

CMS-1403-FC Response: We do not believe that the revisions included in this final rule with comment period will discourage significantly or negatively impact significantly legitimate, nonabusive arrangements. We believe that the revisions strike an appropriate balance between allowing billing physicians and other suppliers flexibility in structuring their arrangements while protecting against program abuse caused by unnecessary diagnostic testing. As explained in section II.I. of this final rule, we are not finalizing our proposals at this time to require physician offices to comply with the IDTF standards in §410.33. Comment: Some commenters stated that there is no evidence that bringing diagnostic services into a physician practice automatically leads to overutilization; rather, many practices do so in order to improve quality of patient care and efficiency and not for financial gain. Response: We disagree with the commenters’ statement that there is no evidence that self-referral of diagnostic services leads to overutilization. We cited several studies in the CY 2008 PFS final rule with comment period that supported the proposition that physician self-referral (that is, the referral of diagnostic tests provided within the physician practice) leads to overutilization (72 FR 66311 through 66312). Additionally, since publication of 434

CMS-1403-FC that rule, the Government Accountability Office (GAO) has published a study indicating the overuse of some diagnostic testing when performed in a physician’s office. The GAO report, Rapid Spending Growth and Shift to Physician Offices Indicate Need for CMS to Consider Additional Management Practices, (GAO-08-452), showed that spending for imaging services paid under the PFS more than doubled over a 6-year period from 2000 through 2006. The report’s findings reflect a link between spending growth and the provision of imaging services in physician offices. The proportion of Medicare spending on imaging services performed in-office rose from 58 percent to 64 percent and physicians received an increased share of their total Medicare revenue from imaging services. We recognize that not all arrangements necessarily lead to overutilization. However, we are not able to regulate per individual practice and instead must issue rules of general applicability to implement statutory intent and address our concerns regarding the potential for overutilization through unnecessary diagnostic testing. b. Statutory Authority Comment: A commenter noted that the anti-markup provisions in section 1842(n)(1) of the Act are limited to “diagnostic tests described in section 1861(s)(3) [of the 435

<strong>CMS</strong>-1403-FC<br />

that rule, the Government Accountability Office (GAO) <strong>has</strong><br />

published a study indicating the overuse of some diagnostic<br />

testing when performed in a physician’s office. The GAO<br />

report, Rapid Spending Growth and Shift to Physician<br />

Offices Indicate Need for <strong>CMS</strong> to Consider Additional<br />

Management Practices, (GAO-08-452), showed that spending<br />

for imaging services paid under the PFS more than doubled<br />

over a 6-year period from 2000 through 2006. The report’s<br />

findings reflect a link between spending growth and the<br />

provision of imaging services in physician offices. The<br />

proportion of Medicare spending on imaging services<br />

performed in-office rose from 58 percent to 64 percent and<br />

physicians received an increased share of their total<br />

Medicare revenue from imaging services. We recognize that<br />

not all arrangements necessarily lead to overutilization.<br />

However, we are not able to regulate per individual<br />

practice and instead must issue rules of general<br />

applicability to implement statutory intent and address our<br />

concerns regarding the potential for overutilization<br />

through unnecessary diagnostic testing.<br />

b. Statutory Authority<br />

Comment: A commenter noted that the anti-markup<br />

provisions in section 1842(n)(1) of the Act are limited to<br />

“diagnostic tests described in section 1861(s)(3) [of the<br />

435

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